Hemangioma
Conditions
Keywords
Hemangioma, Propranolol, prednisolone, steroid
Brief summary
The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.
Detailed description
* Randomized (A group : propranolol, B group : prednisolone) * A group : 3 days admission and medication for 16 weeks * B group : medication for 16 weeks without admission * Hemangioma volume comparison by using MRI * other measurement and drug adverse reaction monitoring
Interventions
DRUGPrednisolone
2mg/kg/day for 16weeks
DRUGPropranolol
2mg/kg/day for 16weeks
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 9 Months
Healthy volunteers
No
Inclusion criteria
* Hemangioma patient ( 0 \ 9 months old) * No treatment before * 10 \ 20 % volume increase in 2 \ 4 weeks * Hemangioma that caused organ function * Hemangioma that will cause aesthetic problem
Exclusion criteria
* Cardiovascular disease (impossible to use propranolol) * Drug adverse reaction or allergy history (propranolol, steroid) * Bradycardia, Atrioventricular block, atrial block * Cardiogenic Shock * Right heart failure (pulmonary hypertension) * Congestive heart failure * Hypotension * Peripheral nerve disease (moderate) * Angina * Hormone deficiency patient * Pulmonary disease (asthma) * diabetic ketoacidosis * laser treatment history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO | After 16weeks | The primary efficacy variable was the clinical response at 16 weeks, classified as follows: when the volume did not increase or decreased by less than 25% after treatment began, we defined it as stop of progression; when the volume decreased by 25% or more compared with the original size, we defined it as regression. Both stop of progression and regressionwere defined as reaction. If the volume at the primary efficacy evaluation point was greater than the size measured when treatment started,we called it an increase. Increase was defined as a nonreaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Which, the Heart Rate Fell to <70% of Acceptable Age Related Minimum Post-dose With Child Awake, Anytime During the 16 Weeks | up to 16weeks | Number of Participants in which, the Heart rate fell to \<70% of acceptable age related minimum post-dose with child awake, anytime during the 16 weeks Count of patients whose Heart rate fall to \<70% of acceptable age related minimum post-dose with child awake |
| Number of Participants With Change in Color as Compared to Baseline | After 16 weeks | Participants were observed for any change in color. The possible change in colors included change to Red/Purple/Blue/Gray/Apricot. Reported are the number of participants who experienced a change in color by the type of color |
| Number of Participants With Size Reduction of Ulceration | After 16 weeks | size was measure the horizontal and vertical size (2-dimension) of ulceration (from baseline to 16 weeks after medication) |
| Number of Participants With Reepithelialzation in 16weeks | After 16 weeks | Number of participants with Reepithelialzation in 16weeks.. |
| Number of Participants With Stop of Proliferation | After 16 weeks | Number of participants whose hemangioma stop proliferating in 16weeks |
| Number of Participants With Regression | Within 16 weeks | Number of participants whose hemangioma showed regression in 16 weeks. |
| Percent Reduction in Hemangioma Volume From Baseline | After 16 weeks | Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 16 weeks)) |
| Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks | up to 16weeks | Number of Participants in Which, the Systolic blood pressure fall of \>25% of baseline postdose with child awake, Anytime During the 16 Weeks.. |
| Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks | up to 16weeks | Number of Participants in Which, Glucose levels fall (to \<50mg/dl), Anytime During the 16 Weeks.. |
| Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks | up to 16weeks | Number of Participants in Which, facial edema occurs, Anytime During the 16 Weeks.. |
| Number of Participants With Growth Retardation Within 16 Weeks | up to 16weeks | Number of Participants with Growth Retardation within 16 weeks.. |
| Number of Participants With Gastroesophageal Reflux Within 16 Weeks | up to 16weeks | Number of Participants With Gastroesophageal reflux within 16 weeks.. |
| Number of Participants With Adverse Drug Reaction | up to 16weeks | All symptoms associated adverse drug reaction will be checked |
| Number of Participants With Drug Compliance Within 16 Weeks | After 16 weeks | We checked Number of participants with Drug compliance within 16 weeks |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prednisolone Patients who will receive prednisolone medication (2 mg/kg/day ) for 16 weeks
Prednisolone: 2mg/kg/day for 16weeks | 17 |
| Propranolol Patients who will receive propranolol medication 2 mg/kg/day for 16 weeks
Propranolol: 2mg/kg/day for 16weeks | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | Prednisolone | Propranolol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 17 Participants | 17 Participants | 34 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.0 months | 3.6 months | 3.3 months |
| Hemangioma volume by MRI | 9,349 mm^3 | 14,125 mm^3 | 11,737 mm^3 STANDARD_DEVIATION 3348 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment South Korea | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 17 | 5 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO
The primary efficacy variable was the clinical response at 16 weeks, classified as follows: when the volume did not increase or decreased by less than 25% after treatment began, we defined it as stop of progression; when the volume decreased by 25% or more compared with the original size, we defined it as regression. Both stop of progression and regressionwere defined as reaction. If the volume at the primary efficacy evaluation point was greater than the size measured when treatment started,we called it an increase. Increase was defined as a nonreaction.
Time frame: After 16weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO | 14 Participants |
| Propranolol | Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO | 16 Participants |
Secondary
Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks
Number of Participants in Which, facial edema occurs, Anytime During the 16 Weeks..
Time frame: up to 16weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks | 5 Participants |
| Propranolol | Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks | 0 Participants |
Secondary
Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks
Number of Participants in Which, Glucose levels fall (to \<50mg/dl), Anytime During the 16 Weeks..
Time frame: up to 16weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks | 0 Participants |
| Propranolol | Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks | 0 Participants |
Secondary
Number of Participants in Which, the Heart Rate Fell to <70% of Acceptable Age Related Minimum Post-dose With Child Awake, Anytime During the 16 Weeks
Number of Participants in which, the Heart rate fell to \<70% of acceptable age related minimum post-dose with child awake, anytime during the 16 weeks Count of patients whose Heart rate fall to \<70% of acceptable age related minimum post-dose with child awake
Time frame: up to 16weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants in Which, the Heart Rate Fell to <70% of Acceptable Age Related Minimum Post-dose With Child Awake, Anytime During the 16 Weeks | 1 Participants |
| Propranolol | Number of Participants in Which, the Heart Rate Fell to <70% of Acceptable Age Related Minimum Post-dose With Child Awake, Anytime During the 16 Weeks | 5 Participants |
Secondary
Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks
Number of Participants in Which, the Systolic blood pressure fall of \>25% of baseline postdose with child awake, Anytime During the 16 Weeks..
Time frame: up to 16weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks | 1 Participants |
| Propranolol | Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks | 5 Participants |
Secondary
Number of Participants With Adverse Drug Reaction
All symptoms associated adverse drug reaction will be checked
Time frame: up to 16weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants With Adverse Drug Reaction | 15 Participants |
| Propranolol | Number of Participants With Adverse Drug Reaction | 16 Participants |
Secondary
Number of Participants With Change in Color as Compared to Baseline
Participants were observed for any change in color. The possible change in colors included change to Red/Purple/Blue/Gray/Apricot. Reported are the number of participants who experienced a change in color by the type of color
Time frame: After 16 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prednisolone | Number of Participants With Change in Color as Compared to Baseline | Red | 13 Participants |
| Prednisolone | Number of Participants With Change in Color as Compared to Baseline | Purple | 0 Participants |
| Propranolol | Number of Participants With Change in Color as Compared to Baseline | Red | 14 Participants |
| Propranolol | Number of Participants With Change in Color as Compared to Baseline | Purple | 0 Participants |
Secondary
Number of Participants With Drug Compliance Within 16 Weeks
We checked Number of participants with Drug compliance within 16 weeks
Time frame: After 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants With Drug Compliance Within 16 Weeks | 15 Participants |
| Propranolol | Number of Participants With Drug Compliance Within 16 Weeks | 17 Participants |
Secondary
Number of Participants With Gastroesophageal Reflux Within 16 Weeks
Number of Participants With Gastroesophageal reflux within 16 weeks..
Time frame: up to 16weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants With Gastroesophageal Reflux Within 16 Weeks | 0 Participants |
| Propranolol | Number of Participants With Gastroesophageal Reflux Within 16 Weeks | 0 Participants |
Secondary
Number of Participants With Growth Retardation Within 16 Weeks
Number of Participants with Growth Retardation within 16 weeks..
Time frame: up to 16weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants With Growth Retardation Within 16 Weeks | 2 Participants |
| Propranolol | Number of Participants With Growth Retardation Within 16 Weeks | 0 Participants |
Secondary
Number of Participants With Reepithelialzation in 16weeks
Number of participants with Reepithelialzation in 16weeks..
Time frame: After 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants With Reepithelialzation in 16weeks | 4 Participants |
| Propranolol | Number of Participants With Reepithelialzation in 16weeks | 8 Participants |
Secondary
Number of Participants With Regression
Number of participants whose hemangioma showed regression in 16 weeks.
Time frame: Within 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants With Regression | 9 Participants |
| Propranolol | Number of Participants With Regression | 13 Participants |
Secondary
Number of Participants With Size Reduction of Ulceration
size was measure the horizontal and vertical size (2-dimension) of ulceration (from baseline to 16 weeks after medication)
Time frame: After 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants With Size Reduction of Ulceration | 2 Participants |
| Propranolol | Number of Participants With Size Reduction of Ulceration | 1 Participants |
Secondary
Number of Participants With Stop of Proliferation
Number of participants whose hemangioma stop proliferating in 16weeks
Time frame: After 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prednisolone | Number of Participants With Stop of Proliferation | 15 Participants |
| Propranolol | Number of Participants With Stop of Proliferation | 17 Participants |
Secondary
Percent Reduction in Hemangioma Volume From Baseline
Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 16 weeks))
Time frame: After 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prednisolone | Percent Reduction in Hemangioma Volume From Baseline | 46.52 % from baseline | Standard Deviation 26.24 |
| Propranolol | Percent Reduction in Hemangioma Volume From Baseline | 55.87 % from baseline | Standard Deviation 18.92 |